What are the responsibilities and job description for the Head of Therapeutic Area Safety position at Lifelancer?

Job Description

Job Title : Head of Therapeutic Area Safety

Job Location : United States

Job Location Type : Remote

Job Contract Type : Full-time

Job Seniority Level :

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Head of Therapeutic Area Safety

Live

What You Will Do

Let’s do this. Let’s change the world. The Head of Therapeutic Area Safety (TAS) is a pivotal global leadership role where you will be responsible for driving innovation, strategic vision, and transformational initiatives for TAS within the Global Patient Safety (GPS) organization. You will have end-to-end accountability for safety across the therapeutic areas of Oncology, Rare Diseases, General Medicine, Obesity, and Inflammation, spanning the product lifecycle from development through post-marketing. You will provide strategic direction, foster integration with cross-functional stakeholders, and prioritize resource allocation to enable alignment with organizational objectives while ensuring compliance.

You will serve as a core member of GPS Leadership team and will support the GPS Vice President (VP) in the establishment of a highly effective global safety organization in full compliance with worldwide regulations. This role reports into the Head of Global Patient Safety.

Responsibilities :

Global Strategic Leadership of Therapeutic Area Safety :

Develop and execute a forward-thinking, innovative strategy for the TAS function aligned with organizational goals and regulatory requirements.
Lead a team of global safety experts across designated therapeutic areas, ensuring benefit-risk optimization, effective risk management, and proactive safety communication.
Drive the integration of cutting-edge safety science, digital health solutions, and data analytics to advance safety practices and decision-making.
Collaborate with Head of Safety to contribute to corporate Portfolio Governance decision making

Oversight of Therapeutic Area Safety Teams :

Oversee Therapeutic Area Heads enabling safety strategic oversight and prioritization.

Establish and prioritize goals for therapeutic area safety teams to achieve key milestones with effective resource capacity planning.

Lead the Therapeutic Area Safety Strategic Committee to ensure consistent application of best practices and continuous improvement initiatives across all therapeutic areas.

Serve as delegate for Head of Safety in governance and committee meetings as needed

Cross-Functional Integration and Leadership :

Collaborate with senior leadership in GPS, Clinical Development, Medical Affairs, Regulatory, Digital Health, Operations, Commercial, Value and Access, and other functions to align safety strategy with business objectives.

Serve as a key safety representative in high-level discussions, fostering a culture of safety excellence and innovation across the organization.

Transformation and Innovation :

Drive transformation initiatives within TAS by leveraging new technologies, AI-driven insights, and evolving safety methodologies.

Promote a culture of innovation by championing continuous learning, cross-functional collaboration, and proactive risk assessment.

Monitor global safety trends and adapt strategies to ensure alignment with industry advancements and regulatory expectations.

Talent Management and Development :

Recruit, retain, and develop a diverse and talented team of safety professionals.

Provide coaching, mentoring, and professional development opportunities to staff, fostering a high-performance and collaborative culture.

Act as a role model for leadership, promoting inclusion, accountability, innovation and strategic thinking within the TAS organization.

Why Join Us?

Be at the forefront of shaping the future of therapeutic area safety, driving transformative initiatives that impact patient lives globally.

Collaborate with top-tier professionals across disciplines to achieve a shared vision of innovation and excellence.

Opportunity to lead in a dynamic and evolving environment, where your strategic insights and leadership will make a lasting impact.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The Head of TAS we seek is an experienced leader with the following qualifications.

Basic Qualifications :

MD or DO degree from an accredited medical school AND

Five (5) years of industry or academic research AND

Six (6) years of managerial experience directly managing people and / or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications :

Experiences within pharmacovigilance, regulatory science, and therapeutic area expertise.

PhD with 15 years of directly related experience

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

Previous product safety experience and knowledge of clinical trials and drug development

Knowledge of patient populations and drug classes

Issue and crisis management

Strategic vision and leadership ability, capable to manage global teams and multifunctional teams to the accomplishment of complex interdepartmental & international programs and projects

Understanding of international drug safety regulations, global pharmacovigilance and product safety processes

Knowledge of general medicine, clinical care, and principles of epidemiology

Influencing skills with capability to present strategies, policy & work processes to diverse audiences, geographies, departments, and organization levels

Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives

Resolving critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting

Identifying diverse, qualified successors for key positions

Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff

They will also embody the Amgen leadership attributes which are :

Inspire : Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

Accelerate : Enable speed that matches the urgency of patient needs by encouraging progress over perfection

Integrate : Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

Adapt : Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Thrive

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $352,570 - $430,918.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities including :

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans and bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements, where possible

Amgen’s Commitment to Our Staff

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Lifelancer ( https : / / lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https : / / lifelancer.com / jobs / view / af962e74f2b052664169f1aec4b4c4d6

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Salary : $352,570 - $430,918

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